Last Updated: May 11, 2026

Details for New Drug Application (NDA): 214310

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NDA 214310 describes ERIBULIN MESYLATE, which is a drug marketed by Baxter Hlthcare Corp, Chia Tai Tianqing, Dr Reddys, Gland, Glenmark Pharms, Jiangxi Kvvit Pharm, Long Grove Pharms, Sandoz, and Xgen Pharms, and is included in nine NDAs. It is available from fourteen suppliers. Additional details are available on the ERIBULIN MESYLATE profile page.

The generic ingredient in ERIBULIN MESYLATE is eribulin mesylate. Sixteen suppliers are listed for this compound. Additional details are available on the eribulin mesylate profile page.

Summary for 214310

Tradename:	ERIBULIN MESYLATE
Applicant:	Sandoz
Ingredient:	eribulin mesylate
Patents:	0

Pharmacology for NDA: 214310

Physiological Effect	Microtubule Inhibition

Suppliers and Packaging for NDA: 214310

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERIBULIN MESYLATE	eribulin mesylate	SOLUTION;INTRAVENOUS	214310	ANDA	Sandoz Inc	0781-3391	0781-3391-94	1 VIAL in 1 CARTON (0781-3391-94) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	1MG/2ML (0.5MG/ML)
Approval Date:	Jun 9, 2025	TE:	AP	RLD:	No

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